- Fresenius Medical Center (Waltham, MA)
- …timely reports, both orally and in writing, to the Director of Compliance Investigations and/or senior management regarding the status of investigations. ... **PURPOSE AND SCOPE:** Under the general direction of the VP of Compliance , this position assists with the development, implementation, and continuous monitoring of… more
- Beth Israel Lahey Health (Boston, MA)
- …with physicians, nurses and fellows. Identifies and resolves problems with protocol compliance . Keeps principal investigator and research nurse aware of any ... staff are in compliance with protocols. (essential) + May assist physician investigator in reviewing data from research protocol in order to assess efficacy of… more
- Sanofi Group (Cambridge, MA)
- **Job Title:** Investigator , Ethics and Business Integrity, North America **Location:** Cambridge, MA **About the Job** Ready to push the limits of what's possible? ... This position is responsible for conducting comprehensive and objective internal Compliance investigations within the North America Ethics & Business Integrity team.… more
- US Tech Solutions (Cambridge, MA)
- …6 months contract** **Job Description:** + The primary responsibility of the ** Senior Oncology Medical Science Liaison** is to serve as **a field-base medical ... Leaders (TL) and Healthcare Providers (HCP) to further patient outcomes.** + The Senior MSL leverages deep scientific and business knowledge in life cycle management… more
- BeOne Medicines (Boston, MA)
- General Description: This role is similar to the ** Senior Medical Science Liaison** role and an individual contributor role. The ** Senior Field Medical Director ... internal partnership across the organization. The candidate will report to the Senior Regional Director, Hematology, within Medical Affairs. As a leader in the… more
- Sumitomo Pharma (Boston, MA)
- …seeking a dynamic, highly motivated, and experienced individual for the position of ** Senior Medical Science Liaison** . The ** Senior Medical Science Liaison** ... drug/brand development. + Identify, initiate, coordinate, evaluate and monitor investigator -sponsored studies intended to support the clinical and scientific… more
- Regeneron Pharmaceuticals (Cambridge, MA)
- …onsite in our Cambridge, MA office. Fully remote is not eligible._ The ** Senior Clinical Study Lead** (CSL) is expected to operate with high-degree of independence ... study design, through execution, to study close out. The Senior CSL is accountable for the study timelines, study...System (CTMS), Trial Master File (TMF) etc. + Ensures compliance with the clinical trial registry requirements + Identifies… more
- Sumitomo Pharma (Boston, MA)
- …. **Job Overview** We are currently seeking a versatile and experienced Senior Manager - Associate Director level scientist with strengths in clinical pharmacology, ... of drug metabolism and bioanalytic chemistry. This position will report to Senior Director of Clinical Pharmacology and Drug Metabolism. S/he will work across… more
- Beth Israel Lahey Health (Boston, MA)
- **Overview** Under general direction, the ** Senior Research Administrator (Research Administrator II)** , provides Pre and Post award support to Joslin investigators ... trials. Post-award responsibilities involve the administration of research projects in compliance with legal, sponsor and Center policies and regulations. This… more
- Actalent (Boston, MA)
- Job Title: Senior Clinical Study Manager The Senior Clinical Study Manager is responsible for ensuring the successful execution and delivery of clinical studies ... + Oversee CRO and vendor selection, scope of work creation, and ensure compliance with quality measures and timelines. + Monitor clinical trial performance and… more
- Dana-Farber Cancer Institute (Boston, MA)
- …of the Principal Investigator (s) and the DFCI Clinical Trials Office. The Senior CRC will be responsible for the primary data collection and management of ... in the clinical trial setting and identifying potential targets for intervention. The Senior CRC supports the research team in the overall conduct of clinical trials… more
- HNTB (Boston, MA)
- …for performing field inspections of construction sites to monitor compliance with engineering plans, specifications, and the project's environmental permits. ... The Construction Compliance Specialist reports on findings and coordinates with the...specifications, contract specifications, and regulatory approvals/permits. + Serves as senior reviewer of technical reports in their entirety, providing… more
- Dana-Farber Cancer Institute (Boston, MA)
- …trials using Good Clinical Practice under the auspices of the Principal Investigator and the Clinical Trials Office. The Clinical Research Manager, in collaboration ... research activities (therapeutic and non-therapeutic), all related regulatory and compliance oversight, and direct supervision of their program's clinical research… more
- Sumitomo Pharma (Boston, MA)
- …evaluation reports according to established safety governance policies and keeping senior leadership informed of safety issues. **Job Duties and Responsibilities** + ... Forms (ICF), Safety Management Plans (SMP), Clinical Study Reports (CSR), Investigator 's Brochures (IB), Investigator communications (Dear Health Care Provider… more
- Beth Israel Lahey Health (Boston, MA)
- **Overview** **The Senior Research Administrator, Post-Award (Research Administrator II)** will, under the direction of the Director, Major Projects and Post Award ... sponsored research post-award portfolio including oversight and management of financial policy, compliance and reporting issues that arise during the life of the… more
- Takeda Pharmaceuticals (Lexington, MA)
- …Medical Affairs Company Sponsored Studies (MACS) collaborative studies and Investigator Initiated Research (IIR). Specific objectives include: + Partners with ... on issues and focus on effective contingencies; interfacing with senior management and influencing decision-making, monitoring slippage and developing strategies… more
- HNTB (Boston, MA)
- …for performing field inspections of construction sites to monitor compliance with engineering plans, specifications, and the project's environmental permits. ... The Construction Compliance Specialist reports on findings and coordinates with the...specifications, contract specifications, and regulatory approvals/permits. + Serves as senior reviewer of technical reports in their entirety, providing… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …the Global Medical budget for nephrology TA. + Acts as a senior company representative interacting with external scientific leaders, patient advocacy groups and/or ... patient organizations, and expert HCPs. + Collaborates with Legal, Ethics, Compliance and Regulatory functions to ensure appropriate interactions between Global… more
- Merck (Boston, MA)
- …Safety (GRACS) and external to GRACS. **Key functions:** + Reports to Senior Principal Scientist ( Senior Director) and/or Distinguished Scientist (Executive ... final approval Worldwide Marketing Applications, Clinical Study Reports, protocols, Investigator Brochures before release from our Company to external agencies… more
- Astellas Pharma (Cambridge, MA)
- …other Medical Heads across Oncology and Biopharma/Cell&Gene and with senior leadership of Clinical Operations, Quantitative Sciences, Regulatory and ... training and quality control, to the highest level of compliance with ICH, GCP and Astellas policies. -Development, mentorship...in pharma or pharma and/ or as a clinical investigator in academia, particularly in the Oncology Solid Tumor… more